About Us

A Desire Beyond Measures

Responding to evolving healthcare needs, Hetero Biopharma is committed to expanding access to affordable, high-quality medicines worldwide.

As the leading biosimilars company, Hetero Biopharma combines robust research and development, state-of-the-art manufacturing, and global commercialization expertise to deliver world-class biologics and biosimilars. Our commitment to quality, accessibility, and innovation continues to drive our mission of improving lives across the globe.

Values that Set Us Apart

Our purpose is to improve lives by developing high-quality, affordable medicines that address healthcare needs worldwide. Guided by our core values, we uphold the highest standards across our internal operations and in our relationships with customers, partners, and shareholders, ensuring that our purpose of improving lives through affordable, high-quality medicines remains at the heart of everything we do.

Knowledge

Integrity

Trust

Agility

Our Defining Feature

We make complex biosimilars Affordable, Available, and Accessible globally to reach out to every patient in need.

Our global regulatory and clinical expertise enables us to rapidly develop and launch complex and niche products using cutting-edge technology. By leveraging advanced technologies, we make critical therapies more affordable, improving patient access and treatment adherence worldwide.

Our flexible business model, which addresses country-specific requirements, allows us to make complex biosimilars available.

We are committed to making the biosimilars and clinical information accessible to all stakeholders through various channels and digital platforms.

Our Strengths

Bringing together diverse strengths to achieve a common goal, from bench to bedside.

Our Strengths

Bringing together diverse strengths to achieve a common goal, from bench to bedside.

Our People: At Hetero BioPharma, we foster an inclusive culture where every employee feels a genuine sense of belonging. Rooted in integrity, respect, collaboration, innovation, and excellence, we value diverse perspectives, empower individual growth, and create opportunities for our people to thrive, contribute, and succeed together.

R&D Capabilities: State-of-the-art R&D infrastructure, advanced analytical platforms, and scientific expertise enable end-to-end development of monoclonal antibodies, Antibody Drug Conjugates (ADCs), and other Biologics. Our integrated capabilities in analytical, upstream, downstream, and formulation development, supports Process optimization, Product characterization, Biosimilarity assessment and scale-up with a focus on product quality, safety, and efficacy enabling accelerated product development and commercialization under one roof.

Robust Cell bank characterization and biosafety testing, conducted in accordance with ICH Q5A/Q5B/Q5D guidelines, verify identity, purity, genetic stability, viability, and free from adventitious agents and viral contaminants, establishing well-characterized cell banks that ensure product quality, manufacturing consistency, and global regulatory compliance.

Bulk Manufacturing: Biologics manufacturing facilities deploy the latest technologies, including 1 kL and 2 kL Single-Use Bioreactors (SUBs), and are equipped with state-of-the-art systems from leading global suppliers. The multi-suite infrastructure provides the capacity to manufacture up to (2.4 lakh litres) annually, enabling supply to large markets. The facilities are designed, built, and operated in accordance with current Good Manufacturing Practice (cGMP) standards.

Drug Product Manufacturing: Integrated drug product facilities offer liquid filling, lyophilization, and pre-filled syringe (PFS) filling capabilities with annual production installed capacities of 25 million liquid-filled vials, 3 million lyophilized vials, and 30 million pre-filled syringes, ensuring flexible and reliable commercial supply across a wide range of biologic product presentations. The facilities are designed to accommodate fill volumes up to 50 mL, supporting diverse product and market requirements.

Contract Development and Manufacturing Services (CDMO): Hetero Biopharma's facilities can support clients with global contract development and manufacturing services. Supported by our integrated R&D, Analytical and biological testing, and manufacturing expertise across diverse product modalities. Our CDMO platform accelerates product development, scale-up, Clinical trial material and commercial manufacturing of monoclonal antibodies and other Biologics.

Regulatory Affairs & Clinical Expertise: Enabling successful product registrations through ICH-aligned regulatory strategies, CTD/eCTD dossier preparation, compliant submissions, and proactive health authority engagement. Our Clinical Development and Medical Affairs (CDMA) team supports clinical development from Phase I to Phase IV, providing clinical strategy, medical oversight, regulatory support, and pharmacovigilance expertise to ensure product safety throughout the product lifecycle.

Project Management: Dedicated Project management professionals provide end-to-end leadership, driving successful execution through technology transfer, stakeholder engagement, third-party management, and cross-functional coordination. Leveraging extensive global experience, we ensure seamless implementation, accelerated timelines, and reliable delivery outcomes.

Global Business Operations: As a result of our in-depth knowledge of biosimilar commercial pathways, we can overcome entry barriers to the early commercialization of biosimilars. A flexible business model defines our passion for taking complex biosimilars across emerging markets through Strategic Partnerships.